Dataset from A Randomised Double Blind (Sponsor Unblinded), Single and Repeat Ascending Dose First Time in Human Study in Healthy Subjects, Cold Urticaria and Chronic Spontaneous Urticaria Subjects to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

This First Time in Human (FTIH) study, which will be performed in three parts, is designed to
investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after
single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding
placebo within the same subject, in healthy adult subjects (Part A), subjects with cold
urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The
study will also measure short term effects of GSK2646264 on the number and size of weals in
subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.

本首次人体（First Time in Human, FTIH）研究分为三个部分，旨在探究健康成人受试者（A部分）、寒冷性荨麻疹（cold urticaria, CU）受试者（B部分）及慢性自发性荨麻疹（chronic spontaneous urticaria, CsU）受试者中，同一受试者内单次及多次局部应用最多两种浓度的GSK2646264及其对应安慰剂后的安全性、局部耐受性、药代动力学与药效动力学。本研究还将测定GSK2646264对CsU受试者风团数量及大小的短期影响，以及激发试验后健康受试者与CU受试者的相关指标。